SchizophreniaNCT02478827
A Trial of Cognitive Training in Schizophrenia
A study testing Cognitive training in people with Schizophrenia, run by University of Calgary at 3 sites in Canada.
Trial summary
Schizophrenia is associated with a wide range of symptoms impacting a number of different domains, including cognitive impairment. Given the array of cognitive deficits associated with schizophrenia and their relationship to daily functioning, numerous research groups have examined the impact of cognitive remediation… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Mar 2016to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Age between 18 and 65 years
- A diagnosis of schizophrenia or schizoaffective disorder
- Minimum IQ of 70
- No uncorrected visual impairment, including colour blindness
- No uncorrected hearing impairment
- Able to provide informed consent
Who cannot join
- Meeting Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) diagnostic criteria for a current major depressive episode, manic episode, or hypomanic episode
- Past 1 month history of electroconvulsive therapy (ECT)
- Past 1 month history of Transcranial Magnetic Stimulation therapy (TMS)
- Past 3 month history of substance abuse
- Diagnosed with a medical condition known to affect cognition (e.g., endocrine disease)
- Score less than 70 on the Wechsler Abbreviated Scale of Intelligence (WASI)
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Schizophrenia Society of Alberta
Calgary
Schizophrenia Society of Alberta
Edmonton
About this study
Schizophrenia is associated with a wide range of symptoms impacting a number of different domains, including cognitive impairment. Given the array of cognitive deficits associated with schizophrenia and their relationship to daily functioning, numerous research groups have examined the impact of cognitive remediation on many aspects of cognition. However, it is currently unclear as to which domains of cognition should be targeted to produce the most widespread and durable benefits for schizophrenia patients. It may be the case that targeting lower-level cognitive processes that are important for higher-level and more complex aspects of cognition may produce the most widespread benefits in cognition and everyday functioning. Relatively few studies have examined the effects of working memory or processing speed training on individuals with schizophrenia, as most studies examine broad-based remediation programs. Thus, there is a need for targeted working memory and processing speed training studies to better understand the mechanisms of cognitive enhancement through training in patients. This study will aim to: 1) investigate near-transfer gains associated with working memory and processing speed training in schizophrenia patients, 2) investigate far-transfer gains associated with working memory and processing speed training (i.e., gains in other neurocognitive domains and social cognition), and 3) investigate real-world gains associated with training (i.e., gains in daily functioning). Towards this aim, 81 schizophrenia patients will be recruited and randomly assigned to a working memory training group, a processing speed training group, or a no training control group. Training will be completed at home for 30 minutes per day, 5 days per week, for a total of 10 weeks. Neurocognitive, social cognitive, and daily functioning measures will be administered both pre- and post-training to detect training-related gains.
- Conditions
- Schizophrenia
- Being tested
- Cognitive training
- Keywords
- Cognitive Training, Working Memory, Processing Speed
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
The neurocognitive training program will be provided by an online platform called BrainGymmer (https://www.braingymmer.com/en/brain-games/). Users will receive an account where they will only have access to the training games they have been assigned to and where their activity will be logged. Participants randomized one of the cognitive training arms will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Working Memory group | Experimental | The neurocognitive training program will be provided by an online platform called BrainGymmer (https://www.braingymmer.com/en/brain-games/). Users will receive an account where they will only have access to the training games they have been assigned to and where their activity will be logged. One experimental group will complete the working memory training, which involves three games: N-back, Multi-Memory, and Moving Memory. These games are designed to engage processes involving updating and manipulation of information. All of the training games are adaptive. Participants randomized to this cognitive training arm will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks. Receives: Behavioral: Cognitive training |
| Processing Speed group | Experimental | The neurocognitive training program will be provided by an online platform called BrainGymmer (https://www.braingymmer.com/en/brain-games/). Users will receive an account where they will only have access to the training games they have been assigned to and where their activity will be logged. One experimental group will complete the processing speed training, which involves three games: Line It Up, Sliding Search, and Bubble Math. These games are designed to engage processes involving thinking speed. Participants randomized to this cognitive training arm will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks Receives: Behavioral: Cognitive training |
| Control group | No intervention | The control group will wait 10-weeks, during which they will receive treatment-as-usual (TAU), which might involve pharmacotherapy, psychotherapy, or both. After the 10-week waiting period, a post-assessment will be completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid intelligence
Measured with Raven's Standard Progressive Matrices and Cattell's Culture Fair Test
Measured: Change from baseline to post-assessment (after 10 weeks of training)
Working Memory
Measured with Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Digit Span, Spatial Maintenance and Manipulation Task, and Visual N-Back Task
Measured: Change from baseline to post-assessment (after 10 weeks of training)
Processing Speed
Measured with Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Symbol Search and Delis-Kaplan Executive Function System (D-KEFS) Color Naming Task
Measured: Change from baseline to post-assessment (after 10 weeks of training)
Secondary outcomes (2)
Executive functions: categorization, set-shifting, and cognitive flexibility
Measured with Delis-Kaplan Executive Function System (D-KEFS) Color-Word Interference Test and Trail Making Test
Measured: Change from baseline to post-assessment (after 10 weeks of training)
Behavioural Impulsivity
Measured with Delay Discounting Task
Measured: Change from baseline to post-assessment (after 10 weeks of training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study start1 Mar 2016
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vina M. Goghari, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478827
- Sponsor's protocol ID
- REB15-0526
- Status last verified
- Oct 2018
- First submitted
- 15 Jun 2015
- Last updated
- 10 Oct 2018
- Results posted
- No
Publications
Lawlor-Savage L, Goghari VM. Working memory training in schizophrenia and healthy populations. Behav Sci (Basel). 2014 Sep 3;4(3):301-319. doi: 10.3390/bs4030301. eCollection 2014 Sep.
PubMed 25379283Cassetta BD, Goghari VM. Working memory and processing speed training in schizophrenia: study protocol for a randomized controlled trial. Trials. 2016 Jan 26;17:49. doi: 10.1186/s13063-016-1188-5.
PubMed 26812902
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Cognitive Training in Schizophrenia
- ClinicalTrials.gov ID
- NCT02478827
- Acronym / sponsor ID
- REB15-0526
- Conditions
- Schizophrenia
- Keywords
- Cognitive Training, Working Memory, Processing Speed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Schizophrenia is associated with a wide range of symptoms impacting a number of different domains, including cognitive impairment. Given the array of cognitive deficits associated with schizophrenia and their relationship to daily functioning, numerous research groups have examined the impact of cognitive remediation on many aspects of cognition. However, it is currently unclear as to which domains of cognition should be targeted to produce the most widespread and durable benefits for schizophrenia patients. It may be the case that targeting lower-level cognitive processes that are important for higher-level and more complex aspects of cognition may produce the most widespread benefits in cognition and everyday functioning. Relatively few studies have examined the effects of working memory or processing speed training on individuals with schizophrenia, as most studies examine broad-based remediation programs. Thus, there is a need for targeted working memory and processing speed training studies to better understand the mechanisms of cognitive enhancement through training in patients. This study will aim to: 1) investigate near-transfer gains associated with working memory and processing speed training in schizophrenia patients, 2) investigate far-transfer gains associated with working memory and processing speed training (i.e., gains in other neurocognitive domains and social cognition), and 3) investigate real-world gains associated with training (i.e., gains in daily functioning). Towards this aim, 81 schizophrenia patients will be recruited and randomly assigned to a working memory training group, a processing speed training group, or a no training control group. Training will be completed at home for 30 minutes per day, 5 days per week, for a total of 10 weeks. Neurocognitive, social cognitive, and daily functioning measures will be administered both pre- and post-training to detect training-related gains.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Working Memory group | Experimental | Behavioral: Cognitive trainingThe neurocognitive training program will be provided by an online platform called BrainGymmer (https://www.braingymmer.com/en/brain-games/). Users will receive an account where they will only have access to the training games they have been assigned to and where their activity will be logged. One experimental group will complete the working memory training, which involves three games: N-back, Multi-Memory, and Moving Memory. These games are designed to engage processes involving updating and manipulation of information. All of the training games are adaptive. Participants randomized to this cognitive training arm will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks. |
| Processing Speed group | Experimental | Behavioral: Cognitive trainingThe neurocognitive training program will be provided by an online platform called BrainGymmer (https://www.braingymmer.com/en/brain-games/). Users will receive an account where they will only have access to the training games they have been assigned to and where their activity will be logged. One experimental group will complete the processing speed training, which involves three games: Line It Up, Sliding Search, and Bubble Math. These games are designed to engage processes involving thinking speed. Participants randomized to this cognitive training arm will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks |
| Control group | No intervention | –The control group will wait 10-weeks, during which they will receive treatment-as-usual (TAU), which might involve pharmacotherapy, psychotherapy, or both. After the 10-week waiting period, a post-assessment will be completed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female
- Age between 18 and 65 years
- A diagnosis of schizophrenia or schizoaffective disorder
- Minimum IQ of 70
- No uncorrected visual impairment, including colour blindness
Key exclusion criteria (6 listed)
- Meeting Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) diagnostic criteria for a current major depressive episode, manic episode, or hypomanic episode
- Past 1 month history of electroconvulsive therapy (ECT)
- Past 1 month history of Transcranial Magnetic Stimulation therapy (TMS)
- Past 3 month history of substance abuse
- Diagnosed with a medical condition known to affect cognition (e.g., endocrine disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive trainingThe neurocognitive training program will be provided by an online platform called BrainGymmer (https://www.braingymmer.com/en/brain-games/). Users will receive an account where they will only have access to the training games they have been assigned to and where their activity will be logged. Participants randomized one of the cognitive training arms will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks. | Behavioural | Processing Speed group, Working Memory group |
Primary outcome
Fluid intelligence
Time frame: Change from baseline to post-assessment (after 10 weeks of training)
Measured with Raven's Standard Progressive Matrices and Cattell's Culture Fair Test
Working Memory
Time frame: Change from baseline to post-assessment (after 10 weeks of training)
Measured with Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Digit Span, Spatial Maintenance and Manipulation Task, and Visual N-Back Task
Processing Speed
Time frame: Change from baseline to post-assessment (after 10 weeks of training)
Measured with Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Symbol Search and Delis-Kaplan Executive Function System (D-KEFS) Color Naming Task
2 secondary outcomes
Executive functions: categorization, set-shifting, and cognitive flexibility
Time frame: Change from baseline to post-assessment (after 10 weeks of training)
Behavioural Impulsivity
Time frame: Change from baseline to post-assessment (after 10 weeks of training)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Background: PubMed 25379283Lawlor-Savage L, Goghari VM. Working memory training in schizophrenia and healthy populations. Behav Sci (Basel). 2014 Sep 3;4(3):301-319. doi: 10.3390/bs4030301. eCollection 2014 Sep.
- Derived from this study: PubMed 26812902Cassetta BD, Goghari VM. Working memory and processing speed training in schizophrenia: study protocol for a randomized controlled trial. Trials. 2016 Jan 26;17:49. doi: 10.1186/s13063-016-1188-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training in people with Schizophrenia, run by University of Calgary at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid intelligence (time frame: Change from baseline to post-assessment (after 10 weeks of training)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02478827, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.